On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer.1
The approval was based on results from the TROPION-Breast01 (NCT05104866) trial, which included 732 patients who had cancer that had worsened despite prior treatment and were no longer candidates for further hormone therapy. They had already received 1 or 2 rounds of chemotherapy.
Participants were randomly assigned to receive either datopotamab deruxtecan-dlnk or a standard chemotherapy of their physician’s choice. Patients who received datopotamab deruxtecan-dlnk had a median progression-free survival of 6.9 months, compared with 4.9 months for those on standard chemotherapy. The difference was statistically significant.
Overall survival was similar between the 2 groups: 18.6 months for those on the new treatment and 18.3 months for those on chemotherapy. This result was not statistically significant.
The most common adverse events included mouth sores, nausea, fatigue, hair loss, constipation, vomiting, and dry eyes. Blood test abnormalities, such as lower white blood cell counts, low calcium, and increased liver enzymes, were also reported.
This approval provides a new option for patients with advanced HR-positive, HER2-negative breast cancer who have already undergone hormone therapy and chemotherapy.
Reference
- FDA. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer. January 17, 2025. Accessed February 10, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast